- Granted Approval by China Ministry of Commerce to Export Detection Kits Globally -
- Obtained CE Certification by European Union -

NEW YORK and SYDNEY, Australia, May 08, 2020 (GLOBE NEWSWIRE) -- Beroni Group (OTCQX: BNIGF; NSX: BTG) (“Beroni” or the “Company”), an international diversified biopharmaceutical enterprise focused on the research, development, innovation and commercialization of therapies and products for treatment of global diseases, is pleased to announce that its development of a medical solution using nanobody technology for the novel coronavirus (COVID-19), in collaboration with Tianjin University in China, has made a significant discovery of 24 types of nanobodies that can be used for the rapid detection and medical treatment of the SARS-CoV-2 virus.  

After the screening of a library containing over one billion nanobody sequences, the scientific team has identified 24 lead nanobody constructs that can bind to the key proteins of coronavirus with high affinity and specificity. The S (spike) protein is the prime target of 8 of these nanobodies which can be used as antiviral therapeutics whilst the other 16 deal with the N (nucleocapsid) protein, which can be used as a marker in diagnostic assays. Compared with the traditional antibody, the nanobody has the advantages of high stability, improved screening/isolation techniques, high absorption rate, superior cryptic cleft accessibility, and low immunogenicity.

Currently the team is using a wide range of techniques, including structural biology, computational biology and protein engineering, to optimize their properties. By further humanizing the nanobodies, the team has reduced their immunogenicity and enhanced the therapeutic efficacy. The development of SARS-CoV-2 binding nanobodies will greatly improve the detection sensitivity and rate of SARS-CoV-2 and facilitate the treatment of COVID-19.

With the discovery of the 24 nanobodies, the research team is now prepared to conduct animal experiments and clinical trials which are expected to yield results within the next 12-18 months. Beroni anticipates working with an international CRO/CDMO provider to expedite this process.   

On a separate note, Beroni is pleased to announce that it has been granted the approval by China’s Ministry of Commerce to export its SARS-CoV-2 IgG/IgM antibody detection kit to overseas countries. Since April 1, 2020, China has restricted the export of coronavirus test kits to overseas countries unless they are approved by the Ministry of Commerce. Beroni’s test kit is already CE certified for the European Union market and has been added to the list of Commercial Manufacturers and Laboratories which have notified the U.S. Food and Drug Administration (FDA) that they have validated serology tests as set forth in Section IV.D of the FDA’s Policy. Beroni has previously submitted for EUA approval for its test kits to the US FDA.

About Beroni Group Limited

Beroni Group is an international biopharmaceutical enterprise dedicated to the innovation and commercialization of drugs and therapies to combat various global diseases such as cancer and infectious diseases.  Its diversified portfolio is comprised of a US FDA approved virus diagnostic kit, an e-commerce platform for the sale of pharmaceutical products and a development pipeline targeting oncology and cell therapies.  Beroni has operations in Australia, United States, China and Japan.  To learn more about Beroni, please visit www.beronigroup.com.

Forward-Looking Statements Disclaimer

This press release contains forward-looking statements or forward-looking information, within the meaning of applicable United States and Australian securities laws with respect to the Company. By their nature, forward-looking statements are subject to a variety of factors that could cause actual results to differ materially from the results suggested by the forward-looking statements. Accordingly, readers should not place undue reliance on the forward-looking statements. Generally forward-looking statements can be identified by the use of terminology such as “anticipate”, “will”, “expect”, “may”, “continue”, “could”, “estimate”, “forecast”, “plan”, “intend”, “believe”, “potential” and similar expressions.

Forward-looking information contained in this press release is based on Company management’s opinions, estimates and assumptions in light of its experience and perception of historical trends, current conditions and expected future developments, as well as other factors that management currently believes are appropriate and reasonable in the circumstances. Forward-looking statements involve significant risks, uncertainties and assumptions, and there can be no assurance that such statements, or its underlying risks, uncertainties and assumptions will prove to be accurate.  Factors that could cause actual results or events to differ materially include, without limitation, risks related to laws, rules and regulation applicable to the Company as well as the industry in which it operates (including in respect of taxes and other levies), economic or market conditions on both a national and global level, currency fluctuations, risks inherent to other entities at a similar stage of development and industry in which the Company currently is, competition from the Company’s competitors, unsatisfactory development or marketing of the Company and/or its products or services, regulatory action or litigation (including product liability claims), and failure to enter into agreements or arrangements with other parties on fair or reasonable terms.  Forward-looking information is made only as of the date on which it is provided and, except as may be required by applicable laws, the Company disclaims any intent or obligation to update such forward-looking information whether as a result of new information, future events or otherwise.

For more information, please contact:

Investor Contact:  Media Contact:
Vivian Chen  Cathy Loos
Impact IR  Impact IR
Phone: 917-449-4918  Phone:  347-334-4135
Email: vivianchen@irimpact.com  Email: cathyloos@irimpact.com